Posts in category: Articles

A Recent Success

Vickie Mickey has just completed training in micro-blading! After many prior training in permanent cosmetics the invention of the micro-blading affords the opportunity to present the perfect eyebrow without all the prior issues in regards to permanent makeup. The micro-blading will last for several years and it will not turn that unpleasant color! Have the eyebrow you want and need now!

Skin Care 101

Skincare cleansers may occlude the skin, preventing other compounds, such as sunscreen, from being absorbed into the skin! Additionally, cleansers inhibit the release of hairs in teleogen phase or dead stage after laser hair removal. Better Options for skin cleanser are clear products that can be seen through compared to opaque products. Opaque or cloudy cleanser formulations contain high molecular weight waxes – such as cetyl alcohol or stearates – which make the skin feel soft. The stearates are deposited on the skin as softners. however, the skin appears dull as the buildup prevents the skin from functioning properly.

NEED AN APPOINTMENT?

NEW OFFICE HOURS

Effective October 5, 2016, will be reducing her office hours to the following schedule: Tuesday, Wednesday, and Thursday from 9AM – 4Pm. After 32 years of working crazy hours, the time has come to be home by 5 PM, to enjoy life a little bit more. On August 27, 2016, Vickie turned 67! Of course, Vickie will continue to teach on Friday at the Cosmetic Therapy Training Center.

Another Notable Event!

Cosmetic Therapy Training Center Celebrates 6 years of training new Cosmetic Therapist in January of 2017. We are happy to report 100% pass rate with the State Medical Board of Ohio!

Tickets for the Columbus Museum of Art Decorators Show House are available at About Face. $20.00 presale

Contact Us

614-457-0448

aboutface@aboutface-ctc.com

New Staff Members

Cassi Lawings, CT our newest Cosmetic Therapist has been recently been promoted to help fill Vickie Mickey’s shoes! Cassi trained with Vickie Mickey in the Cosmetic Therapy Training Center and became licensed August 16, 2016, with the State Medical Board of Ohio. Vickie is so proud of Cassi Lawings and welcomes her to our professional staff. Many of you are already aquainted with Cassi as the beautiful face that greets all at the front desk.

Purchase a laser hair removal procedure package – receive a Clarifying Brightening Polish free! The polish will enable the skin to be smooth and bright.

Purchase a micro-blading eyebrow procedure for just $500.00! Save $100.00

Now offering the Replenix® MD Perfect Peels – this new Perfect Peel is medically supervised by our staff physician. Purchase a series of 3 peels and receive physician consent at no charge, plus permission to purchase one skincare product at ½ off. Have perfect skin by summer!

50% off on all Glo Professional Skincare Products! Hurry! Limited amounts available.

740-A Interstate Drive, West Chester, OH, 45246-1146

Phone

(513) 489-5595

Fax

(513) 489-8083

E-mail:

http://www.medicallaseronline.com

From Syneron Candela’s Website:

“The introduction of this new FDA-cleared handpiece expands the functionality of the GentleYAG® Pro and GentleMax® Pro Nd:YAG laser to treat onychomycosis (nail fungus) in addition to its existing capabilities for hair removal and for the treatment of vascular and pigmented lesions.

Onychomycosis is one of the most commonly diagnosed foot conditions, affecting 10-12 percent of the population1. This prevalent and persistent disorder results in thick, jagged nails that can injure surrounding skin, spawning secondary infections and ulcers. Diabetics are especially at risk with a 34 percent chance of developing fungal nail infection and an increased instance of other complications.2 In those age 70 and up, 50 percent are expected to develop onychomycosis.3

Currently a $1.6 billion market in the United States4, the treatment of nail fungus has been challenging. The previous standard of care has been oral antifungal medications, which carry side effects including the potential for hepatotoxicity (chemical driven liver damage) and a high failure rate. Topical treatments have also resulted in limited success due to their inability to properly penetrate the nail.

Premier Laser Spa has filed bankruptcy!

23 stores across 14 states and over 100 employees. Each shop is an LLC in each state.

At the time of Chapter 11 filing on October 19, there were 15 operating stores. Those were not listed by name. Premier has a management company named Turkey Lake LLC, which is the one that filed the bank. Owned by Ed Naylon. Ted Naylon and Michael Linehon are the owners of Premier.

We feel it is necessary to let you know this before you decide to go get treated at one of these laser spas.

“Microneedling is a classic example of industry and technology getting ahead of the U.S. Food and Drug Administration (FDA), which happens quite frequently in industries with a high rate of entrepreneurial activity. Microdermabrasion products, such as rollers and stamps, have become some of the most popular treatments offered by medical aesthetic facilities and spas, because they offer the patient more youthful-looking, unblemished skin.

Many companies selling microneedling devices register their manufacturing and importing facilities with the FDA, and then list the devices as Class 1 dermabrasion accessory devices, which, in the vast majority of cases, is an incorrect device listing. Because the FDA does not review device listings–and device listing by a company does not mean the device is legal–many of these companies then claim their microneedling devices are “FDA approved.” That is a false statement every time and in every instance it is made, no matter what company makes it. The FDA has never approved any microneedling devices.

Many companies claim their devices should be used with various topical cosmeceuticals, such as ointments, creams, lotions and serums, to assist the topicals in penetrating the deeper layers of the skin. Such devices are regulated not only as medical devices, but also as drug delivery systems and, depending upon the marketing claims used, the ointments, creams, lotions and serums most likely are unapproved new drugs.

The question is whether FDA approval is required. The answer depends upon the device design, its effect on the skin and the claims used to market the device. There is great variation in microneedling products, including:

Length of needles;

Format (roller or stamp); and

Application (electronic, manual or mechanical).

The devices are frequently used alone, but are often marketed as more effective when used with topical products.

FDA regulates needling devices: fact The FDA’s authority to regulate a product as a medical device depends on whether the product is intended to affect the structure/function of the body or to be used for therapeutic reasons. Intended use is an objective inquiry, not a subjective one, and it is determined by examining the labeling, design, function and marketing for the device.

Based upon FDA Imports direct contact with the Center for Devices and Radiological Health (CDRH) at the FDA, it does not regulate microneedling devices when the needles are short enough to not puncture past the outer (dead) layer of the skin, and there are no offensive claims about the product, such as those regarding affecting the structure/function of the body. The FDA has determined that needle length should be no greater than 0.3 mm in length.

However, the FDA does regulate microneedling devices that have needles that will puncture the skin past the outer layer; that claim to affect the structure/function of the body; are for a therapeutic use; or are intended to be used as a delivery mechanism for topical cosmeceuticals.

The FDA has approved needling devices: fiction The FDA has not “approved” any needling device. The firms that claim FDA’s approval cite the fact that they have registered the device with FDA. Registering a manufacturing facility and listing a device simply requires paying a fee and submitting a form to FDA. The FDA does not review the registration or listing to make sure it is correct, and registration does not indicate FDA approval. It only means a company knows how to file paperwork. Claims that a needling device is FDA approved are false claims, as a matter of law, and are subject to enforcement action by FDA, FTC, state regulators and self-regulatory bodies, such as the National Advertising Division of the Better Business Bureau.

FDA permits marketing of needling devices as FDA-regulated medical devices: fiction Though dermabrasion devices may be marketed as medical devices, the FDA does not permit companies to market needling microdermabrasion products as medical devices. In the FDA’s opinion, needling microdermabrasion devices have a different technology, which presents new questions for safety and effectiveness. Thus, to be legally marketed as a medical device, the specific product must first undergo an FDA review and clearance, under the direct to de novo review process. The Pre-Market Notification process (known as the 510(k) clearance) is generally not applicable because there are no predicate devices. Thus far, no one has obtained the requisite clearance from the FDA.

Admittedly there are firms marketing needling products as FDA-regulated medical devices. This is not a case of FDA permitting the sale; it’s rather an issue of FDA’s priorities in enforcing its interpretation of the marketing requirements. Just like not every car that is speeding gets a ticket, not every non-compliant marketing strategy gets FDA enforcement attention … yet.” – Benjamin L. England, Esq. Founder and CEO, Benjamin L. England & Associates, LLC, & FDAImports.com, LLC

Benjamin L. England, Esq. Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in identifying FDA, USDA, FTC, EPA, and state requirements. His representation enables his clients to better understand and fully comply with federal and state requirements, and thereby reduce the risk of regulatory interference with products being imported, exported, or distributed in interstate commerce.